[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Rules and Regulations]
[Pages 20509-20513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1998-F-0072] (Formerly 98F-0165)


Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of requests for a hearing and response to 
objections.

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SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying requests that it received for a hearing on 
the final rule that amended the food additive regulations to provide 
for the safe use of ionizing radiation for the reduction of Salmonella 
in fresh shell eggs. After reviewing objections to the final rule and 
requests for a hearing, the Agency has concluded that the objections do 
not raise issues of material fact that justify a hearing or otherwise 
provide a basis for revoking or modifying the amendment to the 
regulation.

FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1281.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the Federal Register of March 20, 1998 (63 FR 13675), FDA 
published a notice announcing the filing of a food additive petition 
(FAP), FAP 8M4584, submitted by Edward S. Josephson, University of 
Rhode Island, Food Science and Nutrition Research Center, to amend the 
regulations in part 179, Irradiation in the Production, Processing, and 
Handling of Food (21 CFR part 179), to provide for the safe use of 
ionizing radiation for the reduction of Salmonella in fresh shell eggs. 
In response to the petition, FDA issued a final rule in the Federal 
Register of July 21, 2000 (65 FR 45280), permitting the irradiation of 
fresh shell eggs for the reduction of Salmonella at doses not to exceed 
3.0 kiloGray (kGy) (hereafter referred to as the ``egg irradiation 
rule''). FDA based its decision on data in the petition and in its 
files. In the preamble to the final rule, FDA outlined the basis for 
its decision and stated that objections to the final rule and requests 
for a hearing were due within 30 days of the

[[Page 20510]]

publication date (i.e., by August 21, 2000).

II. Objections and Requests for a Hearing

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after 
publication of an order relating to a food additive regulation, any 
person adversely affected by such order may file objections, 
``specifying with particularity the provisions of the order deemed 
objectionable, stating reasonable grounds therefor, and requesting a 
public hearing upon such objections.''
    Under 21 CFR 171.110 of the food additive regulations, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Under Sec.  12.22(a), each objection must meet the 
following conditions: (1) Must be submitted on or before the 30th day 
after the date of publication of the final rule; (2) must be separately 
numbered; (3) must specify with particularity the provision of the 
regulation or proposed order objected to; (4) must specifically state 
each objection on which a hearing is requested; failure to request a 
hearing on an objection constitutes a waiver of the right to a hearing 
on that objection; and (5) must include a detailed description and 
analysis of the factual information to be presented in support of the 
objection if a hearing is requested; failure to include a description 
and analysis for an objection constitutes a waiver of the right to a 
hearing on that objection.
    Following publication of the final rule permitting the irradiation 
of fresh shell eggs for the reduction of Salmonella, FDA received 26 
submissions with objections to the rule within the 30-day objection 
period. All but one of these submissions either expressed general 
opposition to the final rule, or objected to the rule based on issues 
that are outside the rule's scope such as the living conditions and 
practices in commercial egg production. Although most of these letters 
requested a hearing, no evidence was identified in support of any of 
these objections that could be considered in an evidentiary hearing 
(Sec.  12.22(a)(5)). Therefore, these objections do not justify a 
hearing.\1\ The Agency will not discuss these submissions further. The 
one submission raising specific objections was a letter from Public 
Citizen (letter to Docket No. 98F-0165, August 17, 2000). The letter 
from Public Citizen sought revocation of the final rule based on five 
objections and requested a hearing on issues raised by each objection. 
A more detailed response to Public Citizen's objections is found in 
section IV of this document. In addition, FDA also received one letter 
in support of the egg irradiation rule.
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    \1\ FDA also received letters after the close of the objection 
period that expressed general opposition to the egg irradiation 
rule. Tardy objections fail to satisfy the requirements of 21 U.S.C. 
348(f)(1) and need not be considered by the Agency (see ICMAD v. 
HEW, 574 F.2d 553, 558 n.8 (D.C. Cir), cert. denied, 439 U.S. 893 
(1978)).
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III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request 
for a hearing are set out in Sec.  12.24(b). Under that regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, the following: (1) There is a genuine and 
substantial factual issue for resolution at a hearing; a hearing will 
not be granted on issues of policy or law; (2) the factual issue can be 
resolved by available and specifically identified reliable evidence; a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions; (3) the data and 
information submitted, if established at a hearing, would be adequate 
to justify resolution of the factual issue in the way sought by the 
requestor; a hearing will be denied if the data and information 
submitted are insufficient to justify the factual determination urged, 
even if accurate; and (4) resolution of the factual issue in the way 
sought by the person is adequate to justify the action requested; a 
hearing will not be granted on factual issues that are not 
determinative with respect to the action requested (e.g., if the action 
would be the same even if the factual issue were resolved in the way 
sought).
    A party seeking a hearing is required to meet a ``threshold burden 
of tendering evidence suggesting the need for a hearing'' (Costle v. 
Pac. Legal Found., 445 U.S. 198, 214 (1980), reh. denied, 446 U.S. 947 
(1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 
609, 620-21 (1973)). An allegation that a hearing is necessary to 
``sharpen the issues'' or to ``fully develop the facts'' does not meet 
this test (Georgia-Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241 (9th 
Cir. 1982)). If a hearing request fails to identify any factual 
evidence that would be the subject of a hearing, there is no point in 
holding one. In judicial proceedings, a court is authorized to issue 
summary judgment without an evidentiary hearing whenever it finds that 
there are no genuine issues of material fact in dispute and a party is 
entitled to judgment as a matter of law (see Fed. R. Civ. P. 56). The 
same principle applies in administrative proceedings (see Sec.  12.24).
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact ``concerning which a meaningful 
hearing might be held'' (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083, 
1085 (9th Cir. 1982)). Where the issues raised in the objection are, 
even if true, legally insufficient to alter the decision, the Agency 
need not grant a hearing (see Dyestuffs and Chemicals, Inc. v. 
Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911 
(1960)). A hearing is justified only if the objections are made in good 
faith and if they ``draw in question in a material way the 
underpinnings of the regulation at issue'' (Pactra Industries v. CPSC, 
555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not be held to 
resolve questions of law or policy (see Citizens for Allegan County, 
Inc. v. FPC, 414 F.2d 1125, 1128 (D.C. Cir. 1969); Sun Oil Co. v. FPC, 
256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality, such as collateral estoppel, can be validly 
applied to the administrative process (see Pac. Seafarers, Inc. v. Pac. 
Far East Line, Inc., 404 F.2d 804, 809 (D.C. Cir. 1968), cert. denied, 
393 U.S. 1093 (1969)). In explaining why these principles ought to 
apply to an agency proceeding, the U.S. Court of Appeals for the 
District of Columbia Circuit wrote: ``The underlying concept is as 
simple as this: Justice requires that a party have a fair chance to 
present his position. But overall interests of administration do not 
require or generally contemplate that he will be given more than a fair 
opportunity.'' Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 
322 (D.C. Cir. 1972); see also Costle v. Pac. Legal Found., 445 U.S. at 
215-17).

IV. Analysis of Objections and Response to Hearing Requests

    The letter from Public Citizen contains five numbered objections 
and requests a hearing on each of them. FDA addresses each of the 
objections in this document, as well as the evidence and information 
filed in support of each, comparing each objection and the information 
submitted in support of it to

[[Page 20511]]

the standards for granting a hearing in Sec.  12.24(b).

A. Findings of Study Co-Authored by Donald Thayer

    The first objection raised by Public Citizen in response to this 
rule contends that the Agency misrepresented the findings of the 1990 
study co-authored by Donald Thayer (Ref. 1). Specifically, the rule (65 
FR 45280 at 45281) states, ``* * * S. enteritidis was found to have 
similar sensitivities to ionizing radiation as five other strains of 
Salmonella'' (S. is referring to Salmonella) when, in the original 
study, Thayer et al. state, ``S. enteritidis was significantly more 
resistant to ionizing radiation than the other five strains of 
Salmonella tested * * *.'' Public Citizen asserts that by stating the 
findings in this manner FDA gives ``* * * the false impression that the 
same level of radiation can be used to eliminate S. enteritidis as 
other strains of Salmonella.''
    The full sentence in the final rule states that ``Salmonella 
strains, in addition to S. enteritidis, in fresh shell eggs should also 
be reduced by irradiation since S. enteritidis was found to have 
similar sensitivities to ionizing radiation as five other strains of 
Salmonella * * *.'' (65 FR 45280 at 45281). The reasoning supporting 
the statement's conclusion is that because irradiation reduces S. 
enteritidis it would be expected to reduce other strains of Salmonella. 
To the extent that S. enteritidis is more resistant to ionizing 
radiation than the other strains, the conclusion is strengthened. 
Further, FDA made clear in the final rule that irradiation of fresh 
shell eggs at the doses requested in the petition will reduce, but not 
entirely eliminate, microorganisms in eggs (65 FR 45280 at 45281).
    FDA evaluated data provided by the petitioner on the absorbed 
radiation required to achieve inactivation of S. enteritidis in shell 
eggs. The data showed that irradiation at a dose as low as 1 kGy 
reduces the viability of S. enteritidis by 3-log10 (99.9 
percent reduction) (Ref. 2). These data are comparable to the results 
seen by Thayer, et al., in a similar medium inoculated with S. 
enteritidis, which showed a 3- to 4-log10 reduction of this 
pathogen at a dose of 1 kGy (Ref. 1). Furthermore, the standards for 
microbiological safety of fresh shell eggs are independent of the final 
rule permitting the irradiation of fresh shell eggs. Irradiation is a 
potential control point in the mitigation of S. enteritidis and other 
food-borne pathogens. The rule is not predicated on the approved 
treatment, by itself, resulting in fresh shell eggs that are pathogen-
free. FDA is denying the request for a hearing on this point because 
the action would be the same even if the factual issue were resolved in 
the manner sought (Sec.  12.24(b)(4)).

B. Vitamin A Loss

    In the egg irradiation final rule, FDA states that the vitamin A 
retention resulting from the irradiation of shell eggs at a maximum 
absorbed dose of 1.0 kGy (65 FR 45280 at 45281) yields a relative 
retention rate of 76 percent following a 24-day storage period. Public 
Citizen asserts that the final rule misrepresents the vitamin A loss 
from fresh shell eggs following irradiation at 3.0 kGy because FDA 
based these conclusions on vitamin A loss from the results of a study 
that used a maximum dose of 1.0 kGy compared to the maximum petitioned 
dose of 3.0 kGy, whereas another study in the petition showed that 
vitamin A retention by the eggs irradiated at 3.1 kGy and stored for 2, 
15, and 33 days was 41.8 percent, 35.5 percent, and 20.1 percent, 
respectively (Refs. 3 and 4).
    The studies that Public Citizen refers to were included in the 
petition and were analyzed and considered when making the safety 
assessment. FDA acknowledges that stating a vitamin A retention in the 
range of 20.1 to 35.5 percent is more appropriate in light of the 
maximum petitioned dose. Importantly, in its review of the petition, 
FDA considered the health implications from vitamin A loss in eggs at 
the maximum petitioned dose and concluded that the effect on health 
from this vitamin loss is not significant because a variety of foods 
provide vitamin A and the intake of other foods can compensate for any 
loss (Refs. 5 and 6).
    The issue raised by Public Citizen must be a material issue 
concerning which a meaningful hearing might be held (Pineapple Growers 
Ass'n v. FDA, 673 F.2d at 1085). The Agency recognizes that irradiation 
can produce nutrient losses under some conditions and has concluded 
that such effects are not a safety concern under the conditions of this 
regulation. To justify a hearing on the vitamin A issue, Public Citizen 
must provide evidence that the nutritional loss in a food irradiated 
under the conditions of this regulation raises a safety concern because 
of its cumulative effect on the human diet (see 21 U.S.C. 
348(c)(5)(B)). While FDA has the ultimate burden of proof when it 
approves the use of a food additive, once the Agency makes a finding of 
safety in a listing document, the burden shifts to an objector to come 
forward with evidence that raises a material issue of fact with regard 
to FDA's conclusion (American Cyanamid Co. v. FDA, 606 F.2d 1307, 1314 
(DC Cir. 1979)). Public Citizen has submitted no information to support 
that vitamin A loss in fresh shell eggs irradiated under the conditions 
of the regulation is a safety concern. Therefore, this objection does 
not raise a genuine and substantial issue of fact for resolution at a 
hearing. FDA is denying the request for a hearing on this point because 
a hearing will not be granted if there is no genuine and substantial 
factual issue to be resolved (Sec.  12.24(b)(1)).

C. Analysis of Effects of Irradiation on Egg Yolk Carotenoids

    Public Citizen asserts that FDA's analysis regarding the effects of 
irradiation on egg yolk carotenoids is flawed because the information 
used to analyze the nutritional information of egg yolk carotenoids is 
based on doses of 0.5 kGy and 1.0 kGy, not the petitioned maximum of 
3.0 kGy.
    FDA acknowledges that Agency's analysis of the effects of 
irradiation on egg yolk carotenoids was based on studies performed at 
lower doses than the petitioned maximum dose of 3.0 kGy; however, 
because there are a number of commonly consumed foods that are 
substantial sources of carotenoids in the diet, including yellow corn, 
carrots, and squash (Ref. 7), FDA has no health concerns about the loss 
of carotenoids in the diet from the irradiation of eggs. Public 
Citizen's request for hearing suggests that there is potential for harm 
from the loss of carotenoids resulting from the irradiation of shell 
eggs, without providing any evidence to support this suggestion. An 
objector must make an adequate proffer of evidence to support its 
allegations and to show that they provide a basis on which to call into 
question the Agency's conclusions. A hearing will be denied if the 
Commissioner of Food and Drugs (the Commissioner) concludes that the 
data and information submitted are insufficient to justify the factual 
determination urged, even if accurate (Sec.  12.24(b)(3)). FDA 
concludes that the data and information are insufficient; therefore, 
FDA is denying the request for a hearing based on this objection.

D. Request for Updated Analysis for Irradiation of Fresh Shell Eggs Not 
To Exceed 3.0 kGy

    Public Citizen objects to the egg irradiation final rule on the 
grounds that the Agency did not adequately update ``[n]umerous issues 
raised in the two initial analysis [sic]'' after the petition

[[Page 20512]]

was amended to allow for doses up to 3.0 kGy from 1.7 kGy.
    When the petition (FAP 8M4584) was originally submitted, the 
maximum petitioned dose was 1.7 kGy. The petition was subsequently 
amended to increase the maximum dose to 3.0 kGy and additional 
chemistry and toxicology reviews were performed by FDA following this 
amendment. Based on these reviews, FDA concluded that the 3.0 kGy dose 
for shell eggs did not change the general conclusions from the original 
reviews (Refs. 3 and 6). Public Citizen neither specifies the 
``[n]umerous issues'' nor does it provide any information that would 
cause the Agency to change its conclusion that the consumption of 
irradiated shell eggs is safe.
    A hearing will be denied if the Commissioner concludes that the 
data and information submitted are insufficient to justify the factual 
determination urged, even if accurate (Sec.  12.24(b)(3)). FDA 
concludes that the data and information are insufficient; therefore, 
FDA is denying the request for a hearing based on this objection.

E. Bureau of Foods Irradiated Food Committee Report of 1980

    Public Citizen alleges that FDA failed to follow all of the 
recommendations put forth in 1980 by the Bureau of Foods Irradiated 
Food Committee (BFIFC) regarding the evaluation of irradiated foods. 
Specifically, Public Citizen quotes the following from a BFIFC report: 
``Foods irradiated at doses above 100 Krad [1 kGy] and comprising more 
that 0.01% of the diet are estimated to contain URPs [Unique Radiolytic 
Products] in sufficient quantity to warrant toxicological evaluation. * 
* * [T]ests must be performed on extracts in which the concentration of 
radiolytic products is maximized'' (Ref. 8).
    Public Citizen then states that there is no indication in the egg 
irradiation rule or its references that such tests were conducted or 
reviewed by the FDA before the petition was approved.
    The assertion that FDA failed to comply with recommendations set 
forth by the BFIFC committee has been raised previously by Public 
Citizen and others and has been responded to by the Agency in the 
molluscan shellfish final rule (70 FR 48057 at 48069, August 16, 2005) 
and in other previous rulemakings regarding the irradiation of food 
(see, e.g., 53 FR 53176 at 53179, December 30, 1988, and 62 FR 64102 at 
64105, December 3, 1997).
    As discussed previously, the BFIFC report was an internal document 
prepared by FDA scientists that provided recommendations for evaluating 
the safety of irradiated foods based on the known effects of food 
irradiation and on the capabilities of toxicological testing. The 
report was made available to the public for comment in the Federal 
Register of March 27, 1981 (46 FR 18992). While the report and the 
comments received on it have aided FDA's thinking regarding the safety 
testing of irradiated foods, the report established no requirements. 
Furthermore, FDA has not adopted regulations that require toxicological 
testing of a food additive if that additive constitutes a certain 
portion of the diet, and Public Citizen has not cited any regulation 
that imposes such a requirement.
    In addition, the understanding of radiolytic products produced by 
the irradiation of foods has evolved since 1980. As noted in the egg 
irradiation final rule, ``[m]ost of the radiolysis products [of shell 
egg irradiation up to 3kGy] are either the same as, or structurally 
similar to, compounds found in foods that have not been irradiated, and 
are formed in very small amounts.'' (65 FR 45280). Similarly, in the 
Federal Register of December 3, 1997, for the Agency rulemaking on 
irradiation of refrigerated or frozen uncooked meat, meat byproducts, 
and certain meat food products to control food-borne pathogens and 
extend product shelf-life, FDA concluded that, ``[i]n irradiated flesh 
foods, most of the radiolytic products derived from proteins have the 
same chemical composition but are altered in their secondary and 
tertiary structures. These changes are similar to those that occur as a 
result of heating, but in the case of irradiation, such changes are far 
less pronounced and the amounts of reaction products generated are far 
lower.'' (62 FR 64107 at 64110, December 3, 1997).
    Consistent with section 409 of the FD&C Act, the Agency's decision 
on the safety of the irradiation of fresh shell eggs was based on the 
entire record. FDA reviewed and evaluated studies submitted in the 
petition as well as additional toxicology studies of irradiated foods, 
including red meat, chicken, fish and eggs, which are available in 
Agency files. Included in the data considered by the FDA in review of 
the petition were at least three studies conducted specifically on 
irradiated eggs.
    Once the Agency makes a finding of safety in an approval document, 
the burden shifts to an objector to come forward with evidence that 
calls into question FDA's conclusion (see Sec.  12.24(b)(2)). Although 
Public Citizen alleged that the rule did not comply with the 
recommendations in the BFIFC report, Public Citizen did not present any 
evidence that these alleged inconsistencies, even if true, would have 
led to a different conclusion concerning the safety of irradiation of 
fresh shell eggs. Therefore, FDA is denying this objection and request 
for a hearing because it raises no factual issue that, even if resolved 
in the way sought by the objection, would justify the action requested 
(Sec.  12.24(b)(4)).

V. Summary and Conclusion

    Section 409 of the FD&C Act requires that a food additive be shown 
to be safe prior to marketing. Under 21 CFR 170.3(i), a food additive 
is ``safe'' if ``there is a reasonable certainty in the minds of 
competent scientists that the substance is not harmful under the 
intended conditions of use.'' In the Agency's July 21, 2000, final rule 
approving the use of irradiation of fresh shell eggs, FDA concluded, 
based on its evaluation of the data submitted in the petition and other 
relevant material, that this use of irradiation is safe for its 
intended use for the reduction of Salmonella in fresh shell eggs.
    The petitioner has the burden to demonstrate the safety of the 
additive to gain FDA approval. However, once FDA makes a finding of 
safety in an approval document, the burden shifts to an objector, who 
must come forward with evidence that calls into question FDA's 
conclusion (see section 409(f)(1) of the FD&C Act).
    Despite its allegations, Public Citizen has not established that 
FDA overlooked significant information in the record while reaching its 
conclusion that the use of irradiation for reduction of Salmonella in 
fresh shell eggs is safe. Therefore, the Agency has determined that the 
objections requesting a hearing do not raise any genuine and 
substantial issue of fact that would justify an evidentiary hearing 
(Sec.  12.24(b)). Accordingly, FDA is not making any changes in 
response to the objections and is denying the requests for a hearing.

VI. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20857, under Docket No. FDA-1998-F-0072 
(formerly 98F-0165) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site 
address, but FDA is not responsible for any subsequent changes to the 
Web site after this document publishes in the Federal Register.)


[[Page 20513]]


1. Thayer, D. W., G. Boyd, W.S. Muller, et al. ``Radiation 
resistance of Salmonella,'' Journal of Industrial Microbiology, 5: 
383-390, 1990.
2. Memorandum for FAP 8M4584 from V. K. Bunning, FDA, to W. Trotter, 
FDA, April 4, 2000.
3. Memorandum for FAP 8M4584 from K. Morehouse, FDA, to W. Trotter, 
FDA, April 11, 2000.
4. Memorandum for FAP 8M4584 from K. Morehouse, FDA, to W. Trotter, 
FDA, May 14, 1999.
5. Memorandum for FAP 8M4584 from I. Chen, FDA, to W. Trotter, FDA, 
December 11, 1998.
6. Memorandum for FAP 8M4584 from I. Chen, FDA, to W. Trotter, FDA, 
March 31, 2000.
7. U.S. Department of Agriculture, Agricultural Research Service, 
USDA National Nutrient Database for Standard Reference, Release 23, 
Nutrient Data Laboratory Home Page (http://www.ars.usda.gov/ba/bhnrc/ndl), 2010.
8. Bureau of Foods Irradiated Foods Committee, Recommendations for 
Evaluating the Safety of Irradiated Food, Prepared for the Director, 
Bureau of Foods, FDA, July 1980.

    Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8815 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P